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The U.S. regulators who will decide the fate of COVID-19 vaccines are taking an unusual step: Asking outside scientists if their standards are high enough.The Food and Drug Administration may have to decide by year’s end whether to allow use of the first vaccines against the virus. Thursday, a federal advisory committee pulls back the curtain on that decision process, debating whether the guidelines FDA has set for vaccine developers are rigorous enough.“We will not cut corners, and we will only use science and data to make that determination,” FDA Commissioner Stephen Hahn pledged at a meeting of the Milken Institute Wednesday.Exactly how much data his agency needs to be sure a vaccine is safe and effective is a key question for the advisers. An even bigger one: If the FDA allows emergency use of a vaccine before final testing is finished, will that destroy chances of ever learning just how well that shot -- and maybe competitors still being studied -- really work?“We can’t lose sight of the fact that it is in our societal interest to see these trials to completion,” said Dr. Luciana Borio, a former FDA acting chief scientist who will be watching the advisers’ debate.Plus, multiple vaccines are being studied -- shots made with different technologies that each have pros and cons.“The first vaccine is not necessarily the best vaccine,” cautioned Dr. M. Miles Braun, a former FDA scientist now with Georgetown University School of Medicine. If the trials aren’t allowed to finish, it may be difficult or impossible to ever know for sure.It’s a critical moment in FDA’s 114-year history. The government has spent billions to race a vaccine through a research process that usually takes years, and FDA faces unprecedented pressure from the Trump administration, fueling public skepticism that politics could overrule science.Interest is so high, FDA is airing the meeting on YouTube. Here are some key issues the committee will discuss:HOW MUCH EVIDENCE IS NEEDED?FDA is requiring manufacturers to do studies of at least 30,000 people to prove if a vaccine protects and how safe it is. Those studies must include adequate numbers of people at highest risk from COVID-19 -- older adults, minorities and anyone with underlying health problems.FDA has made clear that any vaccine must be at least 50% effective. And while the studies are designed to run for two years, companies may get enough evidence the shots are protective -- in at least some people -- to stop the trials early and seek what’s called an “emergency use authorization” for wider vaccinations.Despite White House objections, the FDA told vaccine makers earlier this month not to seek that speedier review until they’ve tracked at least half their trial participants for two months. With other vaccines, that’s about the amount of time when major side effects crop up.That’s not long enough, said the head of the non-profit ECRI Institute, which reviews medical technology for hospitals and insurers. In comments submitted to the advisory committee, ECRI’s Dr. Marcus Schabacker said FDA should require six months of follow-up.“Doing any less would simply risk too much, and the consequences may be severe,” he wrote. “A weak vaccine that loses public trust could poison the well for epidemic control for many years.”WOULD EMERGENCY USE DERAIL FULL ANSWERS ABOUT VACCINES?Normally when a study ends because of evidence that a vaccine is working, the participants who got dummy shots are offered the real thing.But if FDA allows emergency use of a COVID-19 vaccine, that’s not the same as having full proof the shot works, Borio cautioned.And if the participants in the placebo group are immediately offered the real shot, researchers may not be able to get answers about all the high-risk groups in the study — or tell how long the vaccine’s protection lasts, a process expected to take many more months.But Pfizer Inc., which with Germany’s BioNTech is developing one of the leading candidates, told FDA that if it’s granted emergency use authorization, it “would have an ethical obligation” to alert study participants who got a placebo and allow them vaccine access. The company wants FDA to look into “other scientifically and statistically sound methods” to determine long-term safety and effectiveness.Pfizer’s stance is likely to face pushback. The Infectious Diseases Society of America states that FDA’s panelists “should insist” that vaccine developers “present a compelling case” for how they will complete their trials if FDA grants early authorization of their vaccine.Clearing a vaccine based on premature or faulty data “could cause more harm” by “further eroding public confidence in all vaccines,” the group said.It’s an unprecedented dilemma. The FDA has previously allowed emergency use of only one vaccine, a decades-old shot that in 2005 was authorized to prevent anthrax poisoning.This time around, multiple COVID-19 vaccines are in the pipeline. Pfizer competitor Johnson & Johnson cautioned that early FDA clearance of one vaccine could “jeopardize integrity” of other ongoing trials if patients decide to drop out to seek the first cleared shot instead.The company asked regulators to explain what options are available to ensure completion of all ongoing COVID-19 vaccine trials.WHAT ABOUT LONG-TERM SAFETY MONITORING?Even a study of 30,000 people cannot spot a side effect that only strikes 1 in 100,000. So the government is planning extra scrutiny of every COVID-19 vaccine to hit the market.At first there will be limited doses given to just certain high-risk people -- and those early recipients are to get text messages daily for the first week after vaccination, and then weekly out to six weeks, asking how they’re feeling.FDA also will be checking databases of electronic health records and insurance claims, looking for any red flags.“There’s a kind of tracking that has to take place here on a massive basis that hasn’t taken place before,” said Dr. Jesse Goodman of Georgetown University, a former director of the FDA’s vaccine and biologics center.___The Associated Press Health and Science Department receives support from the Howard Hughes Medical Institute’s Department of Science Education. The AP is solely responsible for all content. 6274
The Seattle Seahawks postponed a workout with free agent quarterback Colin Kaepernick after Kaepernick declined to stop kneeling during the national anthem, ESPN reports.According to ESPN, the Seahawks contacted the former 49ers quarterback two weeks ago to arrange a workout. However, the meeting was canceled at the last minute over the constroversial protest.Kaepernick began kneeling for the national anthem during the 2016 preseason, saying he was hoping to bring attention to police brutality. He continued his protest through the 2016 season, and his contract with the 49ers was not extended following the season.Kaepernick has not played since the 2016, though he is still a free agent and can be signed by any team. In October, Kaepernick filed a grievance against the NFL alleging the owners colluded to blackball him from the league. He was deposed by the league in connection with his complaint earlier this week.Kaepernick's former teammate and fellow free agent Eric Reid was also reportedly asked by Cincinnati Bengals owner Mike Brown about kneeling during the anthem during a workout with the team. Reid said he would continue kneeling, and the Bengals did not offer Reid a contract.Alex Hider is a writer for the E.W. Scripps National Desk. Follow him on Twitter @alexhider. 1355
The United States State Department has lifted a worldwide Level 4 travel advisory which had been in place since the spring amid the spread of the coronavirus.A Level 4 advisory is the highest alert level at the State Department, which warns travelers of life-threatening risks.The State Department still has a number of Level 4 advisories across the globe, including neighboring Mexico.The change in status, however, might not have much impact on travelers as many countries have placed strict limits on non-essential travel from the United States. And with the United States still leading the world in coronavirus cases and deaths, Americans ability to travel internationally is expected to be limited for months to come. 730
The Trump administration has proposed further slashing the number of refugees the United States accepts to a new record low in the coming year.In a notice sent to Congress late Wednesday, just 34 minutes before a statutory deadline to do so, the administration said it intended to admit a maximum of 15,000 refugees in fiscal year 2021. That’s 3,000 fewer than the 18,000 ceiling the administration had set for fiscal year 2020, which expired at midnight Wednesday.The proposal will now be reviewed by Congress, where there are strong objections to the cuts, but lawmakers will be largely powerless to force changes.The more than 16.5% reduction was announced shortly after President Donald Trump vilified refugees as an unwanted burden at a campaign rally in Duluth, Minnesota, where he assailed his opponent, former Vice President Joe Biden. He claimed Biden wants to flood the state with foreigners.“Biden will turn Minnesota into a refugee camp, and he said that — overwhelming public resources, overcrowding schools and inundating hospitals. You know that. It’s already there. It’s a disgrace what they’ve done to your state,” Trump told supporters.Trump froze refugee admissions in March amid the coronavirus pandemic, citing a need to protect American jobs as fallout from the coronavirus crashed the economy.Secretary of State Mike Pompeo said the administration is committed to the country’s history of leading the world in providing a safe place for refugees.“We continue to be the single greatest contributor to the relief of humanitarian crisis all around the world, and we will continue to do so,” Pompeo told reporters in Rome on the sidelines of a conference on religious freedom organized by the U.S. Embassy. “Certainly so long as President Trump is in office, I can promise you this administration is deeply committed to that.”But advocates say the government’s actions do not show that. Since taking office, Trump has slashed the number of refugees allowed into the country by more than 80%, reflecting his broader efforts to drastically reduce both legal and illegal immigration.The U.S. allowed in just over 10,800 refugees — a little more than half of the 18,000 cap set by Trump for 2020 — before the State Department suspended the program because of the coronavirus.The 18,000 cap was already the lowest in the history of the program. In addition, the State Department announced last week that it would no longer provide some statistical information on refugee resettlement, sparking more concerns.Advocates say the Trump administration is dismantling a program that has long enjoyed bipartisan support and has been considered a model for protecting the world’s most vulnerable people.Scores of resettlement offices have closed because of the drop in federal funding, which is tied to the number of refugees placed in the U.S.And the damage is reverberating beyond American borders as other countries close their doors to refugees as well.“We’re talking about tens of millions of desperate families with no place to go and having no hope for protection in the near term,” said Krish Vignarajah, president of the Lutheran Immigration and Refugee Service, a federally funded agency charged with resettling refugees in the United States.Bisrat Sibhatu, an Eritrean refugee, does not want to think about the possibility of another year passing without reuniting with his wife.For the past 2 1/2 years, he has called the caseworker who helped him resettle in Milwaukee every two weeks to inquire about the status of his wife’s refugee case.The answer is always the same — nothing to report.“My wife is always asking me: ‘Is there news?’” said Sibhatu, who talks to her daily over a messaging app. “It’s very tough. How would you feel if you were separated from your husband? It’s not easy. I don’t know what to say to her.”He said the couple fled Eritrea’s authoritarian government and went to neighboring Ethiopia, which hosts more than 170,000 Eritrean refugees and asylum-seekers. Between 2017 and 2019, his wife, Ruta, was interviewed, vetted and approved to be admitted to the United States as a refugee. Then everything came to a halt.Sibhatu, who works as a machine operator at a spa factory, sends her about 0 every month to cover her living expenses in Ethiopia.“I worry about her, about her life,” Sibhatu said, noting Ethiopia’s spiraling violence and the pandemic. “But there is nothing we can do.”He hopes his wife will be among the refugees who make it to the United States in 2021.___Lee reported from Washington. 4558
The US-backed Syrian Democratic Forces have detained a US citizen who had been fighting with ISIS in Syria, a US military official told CNN Thursday.The official added that it appeared that the American citizen surrendered to Kurdish elements of the Syrian Democratic Forces.A spokesperson for the US-led coalition fighting ISIS would not confirm that a US citizen was in the custody of the SDF, referring questions to the US State Department."We have seen those same reports and the SDF as our partner has taken an oath to make sure that any fighters that they capture that they maintain them and bring them to the proper authorities. In this case the proper authorities would be the equivalent of the department of state in the country," Col. Ryan Dillon told reporters at the Pentagon via a video conference from Baghdad."If this was a US citizen it would be the Department of State to find out the updates on that particular person," Dillon added.A State Department official told CNN that the department was aware of the reports but said that they "have no information to share at this time."The Justice Department and the FBI also declined to comment.The Daily Beast was first to report that a US citizen had been detained by the SDF.This isn't the first US citizen fighting for ISIS to be detained by US allies in the region. In March 2016 a US citizen was captured in Iraq by US-backed Kurdish Peshmerga forces.The number of US citizens traveling to Iraq and Syria to join ISIS is thought to be much smaller than other countries and regions such as Western Europe and coalition officials have noted that far fewer foreign fighters have joined ISIS in recent months as the terror group suffers set-backs on the battle field.ISIS' recent defeats have also caused an increase in the number of fighters surrendering to the SDF with Dillon telling reporters that five ISIS fighters, including a local commander, had surrendered this week alone.The-CNN-Wire 1966